Recently, according to the Jiaxing Disease Control and Prevention Center that the nucleic acid detection test kit of COVID-19 has obtained the EU's CE marking. It indicated that the test kit has obtained the qualification to sell in all member countries within the EU.
The principal of the key laboratory project of the pathogenic microorganism of Jiaxing Disease Control and Prevention Center introduced that this project was started in early February and finished in early March.
According to the introduction, the greatest advantage of this test kit was that it did not need the nucleic acid extraction steps. The specimen was directly put in the reaction tube and the nucleic acid release was conducted by the cracking agent in the tube. The released nucleic acid was detected in real-time by fluorescent RT-PCR. "Hence, the test kit could simultaneously release nucleic acid and detect a nucleic acid. It could detect the specimen directly and truly achieve the closed tube detection of "sample in and result out". It could effectively solve the problems caused by the aerosol and reduce indoor pollution and personnel infection opportunities." The principal said.
It was acknowledged that this test kit had high sensitivity and rapid detection speed. The whole process of detection could be finished within 1 hour and it only took 40 minutes with the fastest detection speed. The required time was 1/3 of the fluorescent PCR reagent with the same kind, which was especially suitable for the on-site rapid detection for epidemiological investigators.